Description
CPC Scientific is a globally recognized and leading CDMO specializing in synthetic peptide and oligonucleotide production, with one of the largest research peptide facilities in the world. CPC Scientific works directly with leaders in the biotechnology and pharmaceutical industries to bring life-changing therapeutics and diagnostics to market ranging from early drug discovery stages through clinical trials to commercial manufacturing.
CPC Scientific is seeking a QA Director, to fill a full-time, on-site role in our Rocklin, CA facility. This position will report directly to the CEO and is responsible for overseeing the strategic planning and operational delivery of all QA functions at the new greenfield peptide CDMO manufacturing site.
Will lead the full-lifecycle quality governance throughout site construction, facility validation, trial production and commercial launch. Will establish comprehensive QMS and document control framework fully compliant with FDA 21 CFR Part 210/211, EU GMP, ICH Q Guidelines, USP & EP. Will be responsible for the end-to-end ownership of batch release, deviation/change control/CAPA, validation, data integrity, audit readiness and client quality liaison. This position will build the QA team, manage annual department budget, embed risk-based quality culture, enable smooth commercial commissioning in Q4 2026, sustain permanent regulatory inspection readiness, and ensure consistent compliant & efficient operation of the site quality management system.
This position will interact with all levels within the organization. Professionalism and maintaining confidentiality are an integral part of the job.
DUTIES:
Quality Leadership & Strategy
Develop medium & long-term site quality strategy aligned with multi-client, multi-product commercial peptide CDMO business objectives, deliver annual quality roadmap, department KPIs and yearly budget plan;
Act as the quality representative in leadership meetings, report quality trends, compliance risks and critical quality incidents to Site Quality Head and China HQ;
Establish unified site-wide quality culture, cascade compliance-first, proactive risk and data integrity mindset across all departments;
Benchmark against global top-tier peptide CDMO quality standards, continuously optimize site quality governance model and formulate long-term quality improvement roadmap.
GMP Compliance & Regulatory Oversight
Take full ownership of site-wide compliance with FDA 21 CFR Part 210/211, ICH Q7/Q9/Q10, EU GMP, USP/EP and all applicable global regulatory standards;
Sustain permanent site inspection readiness, fully lead FDA, EMA and other global regulatory on-site inspections, serve as primary site QA contact during all regulatory visits;
Review regulatory submissions, quality agreements, inspection observation responses and remediation CAPA reports, ensure full compliance with all regulatory documentation;
Monitor ongoing regulatory and pharmacopoeia updates globally, timely revise internal QMS documents and deliver site-wide regulatory training sessions;
Govern end-to-end third-party GMP audits and client quality audits, coordinate document preparation, on-site walkthrough, observation classification, corrective action planning and full closure.
Peptide Manufacturing & CDMO Support
Deliver full QA oversight over commercial peptide synthesis, purification, fill-finish and packaging operations, covering pilot, scale-up and full commercial production batches;
Lead full QA governance for technology transfer, manufacturing process changes and process validation, assess quality risks associated with peptide manufacturing workflows;
Hold full authority for batch release of peptide drug substances, intermediates and drug products, conduct comprehensive evaluation of batch records, test results, deviations and validation status to issue release decisions;
Act as dedicated QA liaison for global CDMO clients, align with contractual quality requirements, respond to client quality inquiries, coordinate audit, sample and regulatory filing related quality matters;
Lead cross-functional investigations for client complaints and product quality deviations, design long-term corrective and preventive actions to guarantee stable delivery of client programs.
Documentation & Quality Systems
Oversee construction and continuous maintenance of full site Quality Management System (QMS), including SOPs, manufacturing procedures, specifications, all forms of records, validation documents and batch record systems;
Full ownership of Document Control QA team, build integrated paper & electronic document control workflow, standardize full document lifecycle: drafting, review, approval, issuance, retrieval, revision, obsolescence, destruction and scanning archiving;
Manage archive room layout design, records archiving, borrowing, traceability and confidentiality control; centralized controlled management of batch records, validation protocols/reports, regulatory submission files and client quality documents;
Drive deployment of digital document management system, LIMS and CDS, strictly enforce ALCOA+ data integrity and compliance of electronic records & electronic signatures;
Coordinate document transmission on official regulatory platforms, establish site-wide document confidentiality and tiered access control mechanism to prevent information leakage.
Risk Management & Continuous Improvement
Establish and implement site-wide quality risk management framework in alignment with ICH Q9, cover risk assessment of facilities, equipment, manufacturing processes, analytical methods, documentation, data integrity and supply chain;
Govern closed-loop management of deviations, OOS/OOT, change controls and CAPAs, organize cross-functional root cause analysis, tier risks and track remediation effectiveness;
Build monthly/quarterly quality KPI monitoring system (deviation frequency, CAPA on-time closure rate, audit observation count, batch release turnaround time etc.), compile quality trend analysis reports for leadership review;
Organize internal mock FDA audits and periodic self-inspections, proactively identify potential compliance gaps and implement preventive actions;
Lead site-wide continuous quality improvement initiatives to streamline workflows, mitigate compliance risks and boost efficiency of document control and batch release activities.
Team Leadership & Development
Design onsite tailored QA organizational structure covering Document Control, Compliance & Audit, Batch Release and QMS Specialist streams, oversee team recruitment, role assignment, performance appraisal and daily workload allocation;
Specially manage Document Control QA staff, build tiered training matrix covering GMP regulations, document operation, confidentiality management and audit response to continuously upgrade team competency;
Set individual performance objectives and career development paths for each team member, build local US quality talent pipeline and retain core specialists;
Administer full annual QA department budget including labor cost, digital document management system, archive supplies, outsourced validation and audit consulting, continuously optimize operational expenditure;
Implement EHS standards for all QA roles, standardize safety management of chemical reagents and paper archives in storage rooms, foster a safe, compliant and positive team working environment.
Competencies
Strategic Planning: Capable of designing overseas greenfield site quality strategy and long-term QMS framework, adapt to multi-client peptide CDMO business model;
Compliance & Risk Control: Strong capability to proactively identify and mitigate risks related to GMP, data integrity and document confidentiality;
Business Support: Deep understanding of commercial peptide synthesis, purification and fill-finish workflows, able to independently resolve all types of CDMO client quality requirements;
Team Leadership: Experienced in building & motivating teams with specialized development experience for document control staff;
Communication & Documentation: Excellent cross-functional, US-China HQ, client and regulatory communication, negotiation and formal regulatory drafting skills;
Other Duties:
Other duties as assigned.
Closely collaborate with Manufacturing, QC, Process Development, EHS and Procurement on supplier qualification audits, cleaning validation, environmental monitoring and quality risk assessment;
Strictly protect confidential client manufacturing processes, testing data and commercial information, safeguard overall site information security.
Essential Physical and Mental Requirements
Physical Requirements:
§ Ability to sit at a desk for extended periods.
§ Ability to extensively use computer keyboard, mouse and monitor and other lab equipment.
§ Ability to lift at least 25 +/- pounds.
§ Ability to work in a venue such as a lab, office environment, hotel/conference room, etc., with the possible inclusion of working on the weekends during and after site construction and commissioning phase.
§ Ability to walk, bend, stoop, kneel, twist, turn and use/walk up ladder/stairs, etc., and wear required personal protective equipment (PPE) when needed and access archive rooms, cleanroom labs or manufacturing areas when needed.
§ Ability to conduct on site quality walkthroughs.
Mental Requirements:
§ Ability to work with frequent interruptions and changes in workload priorities and the ability to maintain confidentiality.
§ Ability to utilize excellent analytical, organizational skills and problem solving skills.
§ Ability to manage multiple priorities and delegate responsibilities while maintaining regulatory compliance and operational excellence.
§ Ability to be an independent, self-motivated individual, working in a GMP manufacturing environment with tight schedules.
§ Ability to utilize strong written and verbal English communication skills, being responsive in a timely manner and able to work effectively as part of a team with regulatory agencies and customers.
Fluent English for independent communication with FDA & global clients, drafting regulatory response documents;
Computer Skills: Skilled in MS Office, practical experience with document management systems, LIMS & CDS.
Ability to exhibit proficient knowledge and use of English communication skills, e.g., reading, writing and speaking.
Travel:
Valid drivers’ license and insurance required.
Ability to travel domestically by car or commercial means up to 10% of the time. Valid passport is required and ability to travel to China, if needed.
Other:
§ The above is a list of essential duties and responsibilities for this position. This list is not all-inclusive. This job description may be modified at any time as needed.
§ CPC is an equal-opportunity employer. A pre-employment background check will be required.
Requirements
Qualifications:
Education:
Master’s degree or above in Pharmacy, Pharmaceutical Engineering, Chemistry, Biopharmaceutics or Peptide-related majors. MS/Ph.D. in Pharmaceutical, Organic or Analytical Chemistry preferred.
GMP internal auditor or FDA compliance training certificates preferred.
Work Experience:
Minimum 5 years QA experience in peptide / pharmaceutical CDMO industry, with at least 4 years QA team management experience, proven track record overseeing Document Control QA function;
In-depth knowledge of domestic & international GMP, FDA 21 CFR Part 210/211, ICH Q7/Q9/Q10, EU GMP, USP & EP, full mastery of end-to-end workflows in above listed job duties;
Direct lead experience for FDA & EU regulatory on-site inspections and global client CDMO audits, with successful track record of observation remediation and CAPA closure;
Greenfield GMP site experience in document control system build-up, archive room design and electronic document system rollout is strongly preferred;
Prior QA management experience at USA based peptide/pharma CDMO site is a major plus.
